ANDA 213885

EUGIA PHARMA SPECLTS

FDA Drug Application

Application #213885

Application Sponsors

ANDA 213885

EUGIA PHARMA SPECLTS

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 006

Application Products

002	CAPSULE; ORAL	5MG	0	LENALIDOMIDE	LENALIDOMIDE
003	CAPSULE; ORAL	10MG	0	LENALIDOMIDE	LENALIDOMIDE
004	CAPSULE; ORAL	15MG	0	LENALIDOMIDE	LENALIDOMIDE
005	CAPSULE; ORAL	20MG	0	LENALIDOMIDE	LENALIDOMIDE
006	CAPSULE; ORAL	25MG	0	LENALIDOMIDE	LENALIDOMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-12-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

EUGIA PHARMA SPECLTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213885
            [companyName] => EUGIA PHARMA SPECLTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"2.5MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"5MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"10MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"15MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"20MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"25MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-08
        )

)